
Specialist
2 weeks ago
We are seeking a skilled and detail-oriented specialist to contribute to the quality and compliance of our IT systems, particularly in the pharmaceutical and healthcare domains.
The ideal candidate will deliver high-quality validation documentation, ensure timely execution of validation tasks, and maintain strong alignment with industry standards.
Key Responsibilities:- Data Specialist: Ensure compliance with regulatory requirements by developing and maintaining protocols and reports.
- Cross-Functional Collaboration: Deliver high-quality CSV documentation with strict adherence to timelines and quality standards.
- Technical Documentation: Prepare user manuals, SOPs, and other technical documentation related to data processes.
- Data Activities: Conduct risk assessments, validation testing, and documentation review to ensure data integrity.
- Audit Support: Provide relevant documentation and participate in audit response efforts to maintain data compliance.
- Regulatory Updates: Stay informed about current best practices and align company practices accordingly.
- Training and Development: Train internal teams and stakeholders on data processes and expectations.
- Process Improvement: Enhance data processes and document efficiency for continuous improvement.
- Record Maintenance: Maintain accurate records of all data-related activities and projects.
- Expert Guidance: Provide expert guidance to internal departments and stakeholders as required.
- Bachelor's degree in Computer Science, Engineering, or a related field.
- Proven experience in data within regulated industries like pharmaceuticals or healthcare.
- Strong understanding of GxP compliance, FDA guidelines, and related industry standards.
- Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
- Detail-oriented, with excellent analytical and problem-solving skills.
- Capable of working independently as well as collaboratively in a team environment.
- Flexibility to travel for client visits or perform remote validation execution as needed.
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